Study of LM-305 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) and Other Plasma Cell Diseases

NCT05647512 | Withdrawn Phase 1

• 1 other identifier: LM305-01-102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Phase I/II Study of LM-305 in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Conditions

Relapsed or Refractory Multiple Myeloma; Other Plasma Cell Diseases

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity (DLT)

  DLT is defined as a toxicity (adverse event at least possibly related to LM305) occurring during the DLT observation period

  Cycle 1 of each cohort. Duration of one cycle is 21 days

• Adverse Events (AE) and Serious Adverse Events (SAE)

  The safety profile of LM-305 will be assessed by monitoring the adverse events

  From signing the informed consent form (ICF) until 28 days after end of treatment (EOT) or accept other anti-cancer therapy

Secondary Outcomes (1)

• Area under plasma concentration vs time curve (AUC) for LM-305

  Up to finished cycle 5 (each cycle is 21 days)

Study Arms (2)

LM-305 Dose Escalation

EXPERIMENTAL

Administered intravenously

Drug: LM-305

LM-305 Combination Expansion

EXPERIMENTAL

LM-305 Administered intravenously Dexamethasone Orally

Drug: LM-305; Drug: Dexamethasone

Interventions

LM-305 DRUG

Administered intravenously

LM-305 Combination Expansion; LM-305 Dose Escalation

Dexamethasone DRUG

Administered orally

LM-305 Combination Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Aged ≥18 years old when sign the ICF, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1。
• Life expectancy ≥ 6 months.
• Subjects must show appropriate organ and marrow function in laboratory examinations

You may not qualify if:

• Subjects will be excluded from the study, if they meet any of the following criteria:
• A history of other malignant tumors than multiple myeloma within 3 years prior to first dosing
• Subjects who have severe cardiovascular disease。
• Use of any live attenuated vaccines within 28 da ys prior to 1st dosing of IMP.
• Child-bearing potential female who have positive results in pregnancy test or are lactating.
• Subject who is judged as not eligible to participate in this study by the investigator.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Depei Wu

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 12, 2022
• Study Start: January 18, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11